UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049894 |
|---|---|
| Receipt number | R000056826 |
| Scientific Title | Safety evaluation of endometrial biopsy for ERA/EMMA/ALICE analyses |
| Date of disclosure of the study information | 2023/01/04 |
| Last modified on | 2024/02/19 14:52:13 |
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Basic information
Public title
Safety evaluation of endometrial biopsy aiming to analyze ERA/EMMA/ALICE for patient with repeated IVF failure, recurrent pregnancy losses and chronic endometritis.
Acronym
Safety evaluation of endometrial biopsy for ERA/EMMA/ALICE analyses
Scientific Title
Safety evaluation of endometrial biopsy for ERA/EMMA/ALICE analyses
Scientific Title:Acronym
Safety evaluation of endometrial biopsy for ERA/EMMA/ALICE analyses
Region
| Japan |
Condition
Condition
Safety evaluation of endometrial biopsy aiming to analyze ERA/EMMA/ALICE for patient with repeated IVF failure, recurrent pregnancy losses and chronic endometritis.
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety evaluation of endometrial biopsy aiming to analyze ERA/EMMA/ALICE for patient with repeated IVF failure, recurrent pregnancy losses and chronic endometritis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of complication related to endometrial biopsy for ERA/EMMA/ALICE.
Key secondary outcomes
Assessment of ERA/EMMA/ALICE test suitability of biopsied endometrial samples
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
uterine endometrial biopsy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 43 | years-old | > |
Gender
Female
Key inclusion criteria
Patient with repeated IVF failure, recurrent pregnancy losses and chronic endometritis.
Key exclusion criteria
(1)Patient who dose not fulfill inclusion criteria
(2)Patient who dose not agree with study participation
(3)Patient who are receiving treatment for endometrial hyperplasia or endometrial cancer
(4)Patient who have difficulty for endometrial biopsy due to congenital mullerian duct anomaly, Bleeding tendency and/or who requires hospital admission for anesthesia.
(5)Patient who are pregnant or suspicious of pregnancy
(6)Patient who have psychosomatic problem and have been decided to difficult to participant.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masahito |
| Middle name | |
| Last name | Tachibana |
Organization
Tohoku university graduate school of medicine
Division name
Department of perinatology
Zip code
9808574
Address
1-1 Seiryomachi, Aoba-ward, Sendai, Miyagi, 980-8574 Japan
TEL
0227177254
masahito.tachibana.c1@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masahito |
| Middle name | |
| Last name | Tachibana |
Organization
Tohoku university graduate school of medicine
Division name
Department of perinatology
Zip code
980-8574
Address
1-1 Seiryomachi, Aoba-ward, Sendai, Miyagi, 980-8574 Japan
TEL
0227177254
Homepage URL
masahito.tachibana.c1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku university
Institute
Department
Personal name
Funding Source
Organization
Tohoku university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
We recruited and completed 10 subjects as scheduled. Main out come measured was presence of absence of adverse events. We did not observe any adverse event. Secondary endpoints was percentage of defective specimens which incompatible for analysis. There was no defective specimen and we could obtain result from all specimens from all 10 participants.
Results date posted
| 2024 | Year | 02 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 25 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056826
